Validation strategy, overall

FIGURE I Schematic diagram showing the overall validation strategy, which includes calibration, system validation, and system suitability testing. Figure adopted with ideas from Reference I. 

A validation protocol is necessary to define the specific items and activities that will constitute any validation study. It is advisable for companies to draw up a VMP indicating the overall validation strategy for either the product range or equipment type or the entire site. The protocol must be prepared before initiation of the study and must either include or refer to the documentation required to provide information about a specific process, the parameters involved in that specific process, the personnel responsibilities, and the acceptance criteria. 

The overall computer validation strategy within the Validation Master Plan should be outlined, as well as the life cycle model to be applied and the validation procedures to be used. 

Typically, a BMS is a mixture of software categories it is important, therefore, that the Validation Plan identihes what are the categories of software which make up the system, as well as incorporates the results of the system and component risk assessment into the overall validation strategy. Another important element that feeds into the validation plan is the result of the supplier audit. The validation life cycle presented here is consistent with GAMP Guidance and related case study material. - ... 

The sequence of the construction can then be planned to support the validation. The development of the validation strategy should be developed as part of the overall project execution planning. The strategy for contracting for the validation services is a critical early activity. It is important to identify the process systems that affect or come in contact with the product. These systems must be validated. In a process if chilled water or steam is used to heat the jacket of a vessel but that steam or chilled water never comes in contact... 

The majority of the processes currently used to manufacture biotechnology products employ chromatography columns as the main tool for effective product recovery and purification. The scale-up [39] and validation [40] of this vastly popular unit operation is key for successful implementation of the overall production strategy at large scale and eventual product approval for commercialization. 

Validation plans are documents that tailor a company s overall philosophies, intentions, and strategy to establish performance and computer systems or software adequacy. Validation plans state who is responsible for performing development and validation activities, who identifies which systems are subject to validation, who defines the nature and extent of inspection and testing expected for each system, and who outlines the framework to be followed to accomplish the validation. 

Initially, a single test script under the Analyst validation was envisioned. However, as the complexity of the MassChrom software versions was understood, a data migration and system retirement test plan was required to explain the overall strategy with five test scripts. Further information gathering revealed more complexity, and the number of test scripts rose to 10. 

While it is unlikely that all of the risk assessments that go into an effective Validation Plan will have been done by the time the Validation Plan needs to be written and approved, the plan can still describe how all of the risk assessments discussed above will be used to determine an overall strategy for the validation. 

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